LONDON – The largest-ever genomics study of Clostridium difficile has found an emerging new species of the bacterium is selected to thrive on a Western sugar-rich diet and to produce high levels of resistant spores, adapting it to maximize transmission in hospitals and other health care facilities.
BOGOTA, Colombia - Grupo Laboratorios Imperiales Pharma SA de C.V. (Laboratorios Imperiales), from Jiutepec, Mexico, the distributor of measles-rubella (MR) and measles, mumps and rubella (MMR) vaccines manufactured by Serum Institute of India Pvt. Ltd., was banned from signing public contracts with Mexico's public entities for 27 months and fined MX$1.088 million (US$55,478) after it breached two public contracts with the country's Secretariat of Health to provide the country with vaccines.
PERTH, Australia – San Diego-based Okogen Inc. is taking its clinical trial program to Australia where it will test its lead compound OKG-0301 for acute adenoviral conjunctivitis in the phase II (RUBY) trial.
Telix Pharmaceuticals Ltd., of Melbourne, Australia, and Genesiscare Pty Ltd., a provider of cancer and cardiac services, were cleared to start the Enhancing study, a phase II imaging study comparing the expression of prostate-specific membrane antigen, before and after treatment with Xtandi (enzalutamide, Astellas Pharma Inc.), using PET.
Astellas Pharma Inc., of Tokyo, appointed David Fryrear senior vice president and head of clinical and research quality assurance (CRQA) in its Medical and Development (M&D) organization.
HONG KONG – South Korea is the third biggest pharmaceutical market in Asia following China and Japan. Even though it accounts for 1.8% of the global pharmaceutical market, the country aims to launch at least two blockbuster drugs by 2030. Backed by massive support from the government, Korea's biopharmaceutical industry is focusing on R&D, production and out-licensing to make high-value new drugs.
Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld Asia the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%. "One of the most significant concerns that the FDA had was hepatotoxicity, which is an off-target effect," he added, so the approval came with "some fairly onerous monitoring requirements."
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